A prospective, randomized trial examining the efficacy and safety of
clarithromycin in combination with ethambutol, rifabutin, or both for the
treatment of disseminated Mycobacterium avium complex disease in persons with
acquired immunodeficiency syndrome.
Author(s): Benson CA, Williams PL, Currier JS, Holland F, Mahon LF, MacGregor RR, Inderlied
CB, Flexner C, Neidig J, Chaisson R, Notario GF, Hafner R; AIDS Clinical Trials
Group 223 Protocol Team.
Affiliation(s): Division of Infectious Diseases, University of Colorado Health Sciences Center,
Denver, USA.
Publication date & source: 2003, Clin Infect Dis. , 37(9):1234-43
This multicenter, randomized, open-label phase 3 clinical trial compared the
safety and efficacy of 3 clarithromycin-containing combination regimens for the
treatment of disseminated Mycobacterium avium complex (MAC) disease in persons
with acquired immunodeficiency syndrome. A total of 160 eligible patients with
bacteremic MAC disease were randomized to receive clarithromycin with either
ethambutol (C+E), rifabutin (C+R), or both (C+E+R) for 48 weeks. After 12 weeks
of treatment, the proportion of subjects with a complete microbiologic response
was not statistically significantly different among treatment arms: the
proportion was 40% in the C+E group, 42% in the C+R group, and 51% in the C+E+R
group (P=.454). The proportion of patients with complete or partial responses who
experienced a relapse while receiving C+R (24%) was significantly higher than
that of patients receiving C+E+R (6%; P=.027) and marginally higher than that of
patients receiving C+E (7%; P=.057). Subjects in the C+E+R group had improved
survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence
interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92).
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